Study of MRA in Patients With Rheumatoid Arthritis (RA)

Chugai Pharmaceutical135 enrolled

Overview

This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

135

Conditions

Rheumatoid Arthritis

Interventions

MRA(Tocilizumab)DRUG

8mg/kg/4 weeks for 1 year

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety. * Patients confirmed to have shown the safety in the preceding study. Exclusion Criteria: * Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug * Patients who received any of the following treatments between the start of preceding study and the registration of this study. 1. Plasma exchange therapy 2. Surgical treatment (e.g., operation)

Outcomes

Primary Outcomes

ACR 20% responder rate compared to the pre-treatment in the preceding study

Time frame: throughout study

Frequency and severity of adverse events and adverse drug reactions

Time frame: week0,week4,week8,week12,and LOBS

Secondary Outcomes

Time course of DAS28,compared to the pre-treatment in the preceding study

Time frame: week 0,week 4,week 8,week 12, LOBS

Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study

Time frame: week 0,week 4,week 8,week 12, LOBS

ACR N AUC compared to the pre-treatment in the preceding study

Time frame: week 0,week 4,week 8,week 12, LOBS

Time course of the ACR core set variables compared to the pre-treatment in the preceding study

Time frame: week 0,week 4,week 8,week 12, LOBS

Data from ClinicalTrials.gov

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